The present invention generally relates to closures for containers. More specifically, the invention relates to steam sterilizable closures or port protectors for medical containers.
In certain packaging arts, it is desirable to provide the user with a port through which he can access the contents of a package. For example, in the medical field, ports function as a means for allowing one to access the contents within the container so that they can be infused into a patient, compounded into a second package, or mixed with additional components. To this end, the ports provide a means for receiving a spike or other piercing means. An example of such a container with a port is the VIAFLEX.RTM. container, manufactured by Baxter Healthcare Corporation of Deerfield, Ill. U.S.A.
Especially in the medical field, it is necessary to maintain a portion of the port, specifically the area of the port that receives the spike or piercing means, in a sterile condition. Failure to maintain this internal portion of the port in a sterile condition can result in contamination of the contents of the container that could prove hazardous if the contents are infused into a patient. Accordingly, ports typically include a closure member that is designed to removably seal the port until the port is to be utilized.
Typically, the closure member includes a handle member, a sleeve member, and a guide member. The guide member is received within an internal channel defined by the port and the sleeve member circumstances at least a portion of the exterior of the port when the closure seals the port. A handle member is provided to allow the user to remove the closure from the port. To this end, the handle member is gripped by the user and pulled causing the closure to be removed from the port so that the port can be accessed.
A number of variations of closures and ports are known and used. An example of a port and closure is U.S. Pat. No. 4,573,980 that discloses a closure for a container having an elastic port protector for closing the end of a tubular port, for example, on a solution bag. The port protector defines an outer tubular section having inner and outer ends, and with an inner diameter which is less than the outer diameter of the tubular port on which it is intended to reside. An inner tubular section is connected to the outer tubular section at the outer end and is capable of occupying the bore of the outer tubular end in telescoping relation thereto. The inner tubular section has an outer diameter greater than the inner diameter of the tubular port, to fit into the bore of a tubular port in sealing relation. Handle means is carried on the outer tubular section to aid in removal of the port protector.
Closures for ports must meet a variety of requirements. They must provide protection to the port to maintain sterility. In this regard, they cannot fall off the port and must remain securely attached until removed by the user. They must provide a gripping surface on outer means for allowing the user to remove the port.
Closures or port protectors for steam sterilizable containers typically are difficult to design due to the effect of the extreme temperatures to which they are subjected during autoclave cycles. One solution to this problem has been to gamma-sterilize, i.e. pre-sterilize, a closure before autoclaving the container and closure assembly. This approach, however, is costly, and therefore not suitable for products the market for which is price sensitive.